Combined intracranial and intravenous NK cell therapy for malignant brain tumors
NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors
This trial will test whether giving adults with recurrent malignant brain tumors their own expanded and activated natural killer (NK) cells into the tumor site and into the bloodstream is safe and feasible.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | bevacizumab, immunotherapy |
| Locations | 4 sites (Beijing, Beijing Municipality and 3 other locations) |
| Trial ID | NCT07552233 on ClinicalTrials.gov |
What this trial studies
This multi-center, open-label investigator-initiated trial gives autologous ex vivo–expanded and activated NK cells both directly into the brain and intravenously to adults with malignant solid brain tumors who have progressed after standard treatments. The study uses a dose-escalation design to determine the maximum tolerated dose or maximum feasible dose of the combined intracranial and IV NK-cell regimen. Secondary measures include preliminary anti-tumor activity by progression-free and overall survival, objective response per RANO criteria, and immunologic changes in the tumor microenvironment and peripheral blood. Safety, tolerability, and feasibility endpoints will guide whether further development is warranted.
Who should consider this trial
Good fit: Adults aged 18–70 with pathologically confirmed malignant central nervous system tumors (including recurrent GBM or brain metastasis), at least one evaluable lesion after standard therapy, KPS ≥ 60%, adequate organ/marrow function, and low steroid use are ideal candidates.
Not a fit: Patients who are newly diagnosed, unable to tolerate MRI, have poor performance status, uncontrolled comorbidities, high-dose steroids, or inadequate organ or marrow function are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a new immunotherapy option that slows tumor growth or extends survival for patients with recurrent malignant brain tumors.
How similar studies have performed: NK-cell therapies for brain tumors remain experimental: preclinical data and small early-phase trials have shown some promising signals but clinical benefit is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, age 18-70 years old (both ends included) 2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment 3. Karnofsky Performance Status (KPS) ≥ 60% 4. Life expectancy \> 4 weeks, and must be able to undergo an MRI with contrast 5. Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0) 6. Dexamethasone dose ≤ 4 mg/day or equivalent corticosteroid dose, or no dexamethasone administered 7. Must have adequate organ and marrow function as defined below: * White blood cell count (WBC) ≥ 3 x 10\^9/L * Absolute neutrophil count (ANC) \> 1 x 10\^9/L * Hemoglobin (Hb) ≥ 90 g/L * Platelet (PLT) ≥ 80×10\^9/L * Albumin transaminase (ALT) \& albumin transaminase (AST) \< 1.5 × institutional upper limit of normal (ULN) * Serum creatinine (Cr) \< 1.5 x institutional ULN * Total bilirubin \< 1.5 x institutional ULN * PT \& PTT ≤ 1.25 x institutional ULN 8. No obvious hereditary diseases 9. Normal cardiac function with left ventricular ejection fraction \>55% 10. No bleeding and coagulation disorders 11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and/or there aren't any indications of meningitis 12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately 13. Signed, written informed consent Exclusion Criteria: 1. Active hepatitis B or C virus, HIV infection, or other untreated active infection 2. Pregnant and lactating women 3. Participants with organ failure 4. Participants with a chronic disease requiring immunologic or hormonal therapy 5. Participants with an allergy to immunotherapy and related cells 6. Participants with uncontrolled intercurrent illness 7. Participants with psychiatric illness/social situations that would limit compliance with study requirements 8. Participants with a history of organ transplantation or who are awaiting organ transplantation
Where this trial is running
Beijing, Beijing Municipality and 3 other locations
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Qinhuangdao Runze Hospital — Qinhuangdao, Hebei, China (Not_yet_recruiting)
- Zhengzhou Second Hospital — Zhengzhou, Henan, China (Recruiting)
- Henan Academy of Innovations in Medical Science — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Chenlong YANG, M.D., Ph.D.
- Email: vik.yang@pku.edu.cn
- Phone: (+86)-135-1108-7060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.